Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)

Carl Zeiss Meditec

Status: Not yet enrolling

Conditions: Cataract; Corneal Astigmatism; Corneal Defect; Corneal Deformity; Artificial Lens Implant; Lens Opacities

Treatments: Device: Clinical Prototype BioBase (SN 07 and SN 08)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05458661

B2101CI

Details and patient eligibility

About

The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female 21 years of age and older
• Able and willing to make the required study visit
• Able and willing to provide consent and follow study instructions
• Patients must have understood and signed the informed consent

Exclusion criteria

• Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement
• Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.)
• Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF)
• Known Pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

recruited patient population

Other group

Treatment:

Device: Clinical Prototype BioBase (SN 07 and SN 08)